Devices, systems and methods for on-skin or on-body mounting of medical devices

ABSTRACT

Devices, systems, methods and kits for releasably mounting a medical device on the body or skin of a user are provided. Embodiments include a holder or mounting unit or structure that retains a medical device in a fixed position on a body part of a user or host, such as on the surface of the skin, and/or provides physical and/or electrical coupling to one or more additional components which may be operatively positioned above and/or below the surface of the skin.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/906,444, filed Jun. 19, 2020, which is a continuation ofU.S. patent application Ser. No. 16/049,091, filed Jul. 30, 2018, whichis a continuation of U.S. patent application Ser. No. 14/040,674, filedSep. 28, 2013, now U.S. Pat. No. 10,226,207, which is acontinuation-in-part of U.S. patent application Ser. No. 13/171,401,filed Jun. 28, 2011, now U.S. Pat. No. 9,572,534, which claims thebenefit of and priority to U.S. Provisional Application No. 61/359,816,filed Jun. 29, 2010, all of which are incorporated herein by referencein their entireties for all purposes.

BACKGROUND

There are many instances in which it is necessary to maintain a medicaldevice “on-body”, i.e., secured to a body part of a patient, e.g., theskin of an arm, abdomen, or elsewhere. One such instance is maintaininga component of an analyte monitoring system, e.g., a continuous analytemonitoring system, on the skin of a patient. Monitoring of the level ofcertain analytes may be vitally important to the health of certainindividuals. In this regard, devices and systems have been developed forcontinuous or automatic monitoring of analytes in the blood stream orinterstitial fluid. One common application of such analyte monitoringsystems is in the monitoring and measurement of glucose levels indiabetic patients. Such measurements can be especially useful inmonitoring and/or adjusting a treatment regimen, which may include theregular and/or emergent administration of insulin to the patient.Examples of such sensors and associated analyte monitoring systems canbe found in U.S. Pat. Nos. 6,134,461; 6,175,752; 6,284,478; 6,560,471;6,579,690; 6,746,582; 6,932,892; 7,299,082; 7,381,184; 7,618,369 and7,697,967; and U.S. Patent Publication Nos. 2008/0161666, 2009/0054748,now U.S. Pat. No. 7,885,698, 2009/0247857, now U.S. Pat. No. 8,346,335,and 2010/0081909, now U.S. Pat. No. 8,219,173, the disclosures of eachof which are incorporated by reference herein.

Many of these analyte monitoring systems include an in vivo sensor thatis configured so that at least a portion of the sensor is positionedbelow the skin, e.g., in a blood vessel or in the subcutaneous tissue ofa patient. The sensor communicates analyte information to a componentpositioned above the skin where, in certain embodiments, the componentis intended to be maintained or worn on the skin of the patient. Thison-skin or external component, in many systems, includes a control unitwhich has a housing which typically contains most or all of theelectronic components of the analyte monitoring system. The housing istypically configured to couple or mate with one or more other portionsof the control unit and with the sensor, or otherwise allows passage ofthe sensor therethrough, while providing electrical contact between thecontrol unit electronics and the sensor.

Implantable or partially implantable sensors are almost alwayssingle-use devices with a limited useful sensing life, for examplebetween about 3 and about 10 days, while the electronic components of asensor system are typically reusable. As such, multiple sensors are usedand replaced using the same on-skin/on-body control unit, thus requiringnumerous physical and electrical couplings and decouplings between thecontrol unit and sensors. Replacement of the control unit battery alsorequires some decoupling and recoupling of at least a portion of thecontrol unit. Accordingly, it is important that the mechanisms and/orstructures that enable the repeated coupling and decoupling ofcomponents be reliable and durable, yet easy enough for a patient tomanipulate.

With the increasing popularity and use of on-skin or on-body medicaldevices, such as continuous analyte monitoring devices, there continuesto be an interest in improving the structures by which and the manner inwhich the on-skin/on-body components of medical devices, arecoupled/decoupled/recoupled to/from the skin and/or to each other.

SUMMARY

Generally, the present disclosure includes devices, systems, methods andkits for retaining a medical device on-body and/or removing a medicaldevice from an on-body position and/or coupling/decoupling one or moreportions of a medical device. Many of the inventive features facilitateremoving disposable components from the reusable components of themedical device, such as when the disposable component, e.g., animplantable component, battery, etc., has reached its useful operativelife or has expired.

Embodiments include a holder or mounting unit or structure that retainsa medical device in a fixed position on a body part of a user or host,such as on the surface of the skin, and/or provides physical and/orelectrical coupling to one or more additional components which may beoperatively positioned above and/or below the surface of the skin. Incertain embodiments, the medical devices are analyte monitoring systemswhich include an analyte sensor which is at least partially implantablebelow the skin surface and an analyte sensor control unit which ispositionable above the skin surface.

In certain embodiments, the subject holders or mounting structuresinclude a first portion and a second portion, wherein the second portionis moveable relative to the first portion for releasing at least aportion of the medical device from the structure when operativelymounted thereon. The holders or structures may further include a thirdportion extending between the first and second portions, wherein thethird portion is configured to be alterable from a first state to asecond state to provide the relative movement of the second portion tothe first portion. In some of these embodiments, the third portion isreturnable to the first state upon being altered to the second state,while in others, the third portion is not returnable to the first stateupon being altered to the second state, for purposes, for example, ofrendering the holder/structure inoperable to prevent its re-use.

In other embodiments, the subject holders or mounting units may betransformable from a first state to a second state, e.g., by a medicaldevice release feature, or otherwise. A first state may include auseable state and a second state may include a release and/or anun-useable state. In certain embodiments, at least a portion of a holderis moved axially, rotationally, pivotally and/or arcuately relative toat least another portion of the holder after a medical device has beenattached to the holder, and the movement of the at least one portion ofthe holder relative to another enables detachment of the medical deviceor a component thereof from the holder.

Additional embodiments provide assemblies including a medical device anda holder or mounting unit for releasably retaining the medical device onthe body of a user, where the medical device and the mounting unit arecooperatively configured to releaseably and matingly engage with eachother. In certain of these embodiments, the mounting unit includes adisplaceable portion wherein displacement of the displaceable portion atleast partially releases the medical device housing from the mountingunit. The displacement provided by the displaceable portion comprisesone or more of linear, axial and angular movement. The displacement maybe affected by a low-force pressure against the displaceable portion ina direction away from the medical device. The releasable couplingbetween the medical device and mounting unit may be provided bycorresponding mating features on both components whereby effectingdisplacement of the displaceable portion decouples the correspondingmating features. A second pair of corresponding features for releasablycoupling the medical device with the mounting unit may be providedwherein displacement of the displaceable portion of the mounting unitmay or may not decouple the second corresponding features.

The present disclosure also includes methods, such as methods of using amedical device on the body of a host, which includes mounting themedical device on the body of the host by a mounting unit affixed to theskin surface of the host, operatively using the medical device for apredetermined period of time, and then displacing a first portion of themounting unit relative to a second portion and thereby releasing themedical device from the mounting unit. Certain of the methods furtherinclude replacing at least one component of the medical device,returning the displaced first portion of the mounting unit to the firstposition, and operatively reusing the medical device for thepredetermined period of time. Other methods include removing the medicaldevice from the mounting unit, replacing at least one component of themedical device, mounting the medical device on the body of the host bymeans of a second mounting unit affixed to a second location on the skinsurface of the host, and then operatively reusing the medical device forthe predetermined period of time.

These and other objects, advantages, and features of the presentdisclosure will become apparent to those persons skilled in the art uponreading the details of the present disclosure as more fully describedbelow.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure is best understood from the following detaileddescription when read in conjunction with the accompanying drawings. Itis emphasized that, according to common practice, the various featuresof the drawings are not to-scale. On the contrary, the dimensions of thevarious features are arbitrarily expanded or reduced for clarity.Included in the drawings are the following figures:

FIG. 1A illustrates a side view of a medical device holder according toan embodiment of the subject disclosure;

FIG. 1B illustrates an enlarged fragmented view of a portion of theholder of FIG. 1A denoted by area B;

FIG. 1C illustrates an enlarged cutaway plan view of a portion of theholder of FIG. 1A;

FIG. 2 illustrates the holder of FIGS. 1A-1C in a medical device releaseconfiguration;

FIG. 3A illustrates the holder of FIGS. 1A-1C operatively holding amedical device;

FIG. 3B illustrates an enlarged fragmented view of a portion of theholder and medical device denoted by area B of FIG. 3A; and

FIG. 4 illustrates the holder of FIGS. 1A-1C in a medical device releaseconfiguration.

DETAILED DESCRIPTION

Before the present disclosure is described, it is to be understood thatthe present disclosure is not limited to particular embodimentsdescribed, as such may, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular embodiments only, and is not intended to be limiting, sincethe scope of the present disclosure will be limited only by the appendedclaims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the present disclosure. The upperand lower limits of these smaller ranges may independently be includedin the smaller ranges as also encompassed within the present disclosure,subject to any specifically excluded limit in the stated range. Wherethe stated range includes one or both of the limits, ranges excludingeither or both of those included limits are also included in the presentdisclosure.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which the present disclosure belongs. Although any methodsand materials similar or equivalent to those described herein can alsobe used in the practice or testing of the present disclosure, thepreferred methods and materials are now described.

It is understood that the present disclosure supercedes any disclosureof an incorporated publication to the extent there is a contradiction.The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosure.

As summarized above, embodiments of the present disclosure includedevices and methods for maintaining a medical device in place on thebody of a patient and/or removing a medical device from a body surface.Embodiments may be applicable to any medical device, including analytemonitoring devices and systems such as those using an analyte sensor(electrochemical, optical, etc.) wherein at least a portion of thesensor is positionable beneath the skin of the user or host for the invivo determination of a concentration of an analyte in a body fluid,e.g., interstitial fluid, blood, urine, etc. Such an analyte sensor maybe, for example, constructed to be at least partially subcutaneously (orelsewhere) positionable in a patient for the continuous and/or periodicmonitoring of an analyte in a patient's interstitial fluid. The sensorsalso include in vivo analyte sensors positionable in a body vessel suchas a vein, artery, or other portion of the body containing fluid. Thesensors may have an ex vivo portion which is positionable outside thebody, i.e., above the skin surface, and configured to be coupled to acomponent of the medical device system such as to a control unit housingmounted on the skin of the patient.

Sensors described herein may be configured for monitoring the level ofthe analyte over a time period which may range from minutes, hours,days, weeks, one month or longer. Of interest are analyte sensors, suchas glucose sensors, that are capable of providing analyte data of a userfor, and therefore have an in vivo operational life of, about one houror more, e.g., about a few hours or more, e.g., about a few days ofmore, e.g., about three days or more, e.g., about five days or more,e.g., about seven days or more, e.g., about several weeks or months.

Analytes measurable by the subject sensors may include, but are notlimited to, glucose, lactate, acetyl choline, amylase, bilirubin,cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB),creatine, DNA, fructosamine, glucose, glutamine, growth hormones,hormones, ketones, lactate, peroxide, prostate-specific antigen,prothrombin, RNA, thyroid stimulating hormone, and troponin. Other ofthe subject sensors may be configured to detect and measure drugs, suchas, for example, antibiotics (e.g., gentamicin, vancomycin, and thelike), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin.Two or more analytes and/or drugs may be monitored at the same ordifferent times, with the same or different analyte sensor(s). Ifdifferent sensors are employed, they may be coupled together, e.g.,physically and/or electrically.

The subject analyte monitoring systems include an on-skin or externalcomponent having a housing which typically contains most or all of theelectronic components of the analyte monitoring system, also referred toas a control unit. The on-body or on-skin control unit housing typicallyhas a shape and profile which are comfortable for the patient and permitconcealment. The housing often includes a base or mounting structurewhich is configured for engagement with the skin, such as by an adhesivelayer, patch or strip, or by strapping it to the body. The control unitmay include data processing and communication electronics, the latter ofwhich may include a transmitter for relaying or providing data obtainedusing the sensor to another device such as a remotely located device.The control unit may also include a variety of optional components, suchas, for example, a receiver, a power supply (e.g., a battery), an alarmsystem, a display, a user input mechanism, a data storage unit, awatchdog circuit, a clock, a calibration circuit, etc. A remote unit, ifemployed with the on-skin control unit, may include one or more of thesame components and additional components such as an analyte measurementcircuit for use with an in vitro sensor, a pager, a telephone interface,a computer interface, etc.

While embodiments of the subject disclosure are further primarilydescribed with respect to analyte monitoring devices and methods such asglucose monitoring devices and methods, such description is in no wayintended to limit the scope of the present disclosure. It is understoodthat the subject disclosure is applicable to any medical device in whichat least a portion of the device is intended to be maintained in placeon a patient for a predetermined period of time.

Embodiments of the subject holders/mounting units include a medicaldevice area that connects a medical device to the holder, and a bodyattachment area that attaches the holder to a body part of a user, wherethe medical device and body attachment areas may be the same ordifferent areas, including at least partially overlapping areas.

A medical device area may contain one or more features to attach amedical device to a holder, e.g., corresponding mateable features on aholder and a medical device, such as one or more clip(s), rail(s),hook(s), tab(s), groove(s), slot(s), guide(s), orifice(s), adhesive(s),and the like. For example, certain holder embodiments may include a pairof elongated, parallel side rails that slideably receive a medicaldevice to anchor it to the holder. Embodiments may include a medicaldevice that has a first mating member and a holder that has a secondmating member, where the second mating member is adapted to mate withthe first mating member so that the first and second mating membersinterlock or otherwise engage with each other. In an embodiment, thefirst mating member may include at least one tab positioned on or in themedical device. The second mating member may include a receiving area,e.g., that includes a depression or orifice or tunnel, or the like, andbe positioned on or in a holder and which is adapted to mate with theleast one tab so that the at least one tab and the receiving areacooperate together to form an interlocking structure that retains themedical device and holder together, e.g., by frictional engagement, snapfit engagement, or the like. First and second mating members may beselectively engageable and disengagable such that mated arrangementprevents separation of the medical device and the holder when engaged,but are otherwise easily disengageable when desired. Such ease ofcoupling and decoupling components is useful, for example, when abattery or sensor requires replacement.

A body attachment area may include one or more features, including butnot limited to one or more of a strap, latch, adhesive, filaments orthreads, or other fasteners, to maintain or anchor a holder and a heldmedical device on a body of a user such as an arm, leg, abdomen, etc.for a period of time such as the operating life of the sensor. Exemplarytechniques and fasteners that may be employed include but are notlimited to embodiments described in U.S. Pat. No. 6,175,752, and U.S.Patent Publication No. 2010/0049025, now U.S. Pat. No. 7,951,080, thedisclosures of which are herein incorporated by reference. A holder maybe secured to a body prior to or after attaching a medical device to theholder.

A holder may also include an area for interaction with an analytesensor, e.g., a portion of a sensor that protrudes from the skin while aportion of the sensor is positioned beneath the skin (e.g., in thesubcutaneous space, or the like). A holder may include one or more of aport, cavity, surface, protrusion, and/or other feature that receives orotherwise interacts with at least a portion of an analyte sensor.Embodiments of a holder may include a conductive material portion (e.g.,metal, carbon, conductive polymer (carbon impregnated polymers, and thelike), etc.) to electrically contact conductive material of a sensorand/or of a medical device to establish electrical connection. One ormore moisture barriers may be provided to encompass this area about theelectrical contacts of the sensor and the holder and/or medical deviceto provide resistance and/or impermeability to moisture, includingpreventing moisture ingress to the contacts and/or other electricalcomponents of the holder and/or sensor and/or medical device. Moisturebarriers include sealants that may include polymers such as elastomersand the like. Barriers may be malleable and may provide increasedresistance to shock and/or vibration.

As described herein, a holder and/or medical device may include one ormore structures, e.g., cooperating structures, to hold the medicaldevice in a fixed position relative to an analyte sensor, and/or to theholder itself e.g., interlocking features, guide features, railfeatures, etc. Embodiments of the medical device holders include atleast one medical device release feature that at least assists in, andin some embodiments completes, release of a medical device from theholder when the medical device is connected thereto. The one or moremedical device release features may alter the holder when engaged toinitiate release of a medical device. Altering, which may includebreaking, the holder may cause the cooperating structures to bedissociated or released from each other so the medical device can beremoved from the holder, e.g., slid away from the holder. Any of theholder-altering actions described may temporarily or reversibly orpermanently alter a holder and/or medical device and/or sensor.

Embodiments include a displaceable area of a holder that is movablerelative to the holder, e.g., twistable, or bent, or deformable, orotherwise flexed in one or more directions relative to an axis of theholder and/or relative to one or more other portions of the holder.Embodiments include a frangible or breakable area. A frangible area mayinclude a weakened area such as an area of material that is less durablethan a surrounding area. Some holders may include an area of reducedmass, material thickness, scoring, or the like. The area may include agripping portion that enables an area of the holder to be displacedrelative to at least one other area of the holder, permitting, includingcausing, a medical device held by the holder to be released and/oraltering the holder to prevent further use.

In some embodiments, a holder may be a single use holder designed andintended and used to hold a single medical device, after which theholder is discarded. Certain embodiments include a reusable holder suchthat a given holder may be designed and intended and used to hold afirst medical device, and at least a second, subsequent medical device,with the same or different analyte sensors. In order to render a holderoperable, the detachable portion may be replaceable with itself (e.g.,not completely destructed) after detachment or with another detachableportion in some instances.

In certain embodiments, a medical device release feature may include amedical device attachment feature, or vice versa, e.g., may be the samefeature in some instances. In certain embodiments, altering of a holdermay prevent continued use of the holder and/or medical device and/orsensor. For example, a feature may alter the physical and/or structuralintegrity of a holder (e.g., disfigure) so that it is unable tothereafter be used, e.g., unable to receive a sensor and/or couple amedical device and/or be secured to a body part and/or establishelectrical communication. In certain embodiments in which a holderincludes electrical contacts, altering may include rendering theelectrical contacts unusable. This may include modifying one or more ofthe electrical contacts in shape and/or electrical conductivity, and thelike. In certain embodiments, a holder may be reversibly altered, e.g.,temporarily, or may be permanently altered. For example, a holder may betemporarily or permanently deformable. Embodiments that are reversiblyaltered may include a user intervention feature that requires a user totake action to render the holder useable once it has been renderedunusable, and in other embodiments, it may not require userintervention, e.g., may revert to an operable state automatically, e.g.,after a certain action or period of time has occurred.

FIG. 1A illustrates an exemplary embodiment of an on-body medical deviceholder, base or mounting unit 10. Holder 10 includes a support body 14adapted to be held on a skin surface of a user of a medical device 30held by holder 10 (see FIG. 3A). Support body 14 may be flexible orrigid, and may include one or more flexible areas and/or one or morerigid areas. In the embodiment of FIG. 1A, holder 10 further includes anadhesive member 12 provided on the bottom surface of support body 14 fortemporarily attaching holder 10 to a skin surface for a period of time,e.g., as described herein. Support body 14 includes a first or mainportion 14 a, a second or release portion 14 b, which is shown infragmented views in FIGS. 1B and 1C, and a third or transition portion14 c extending between the main and release portions 14 a, 14 b. Supportbody 14 may have a substantially planar construct having a bottomsurface configured for placement on a skin surface and a top surfaceconfigured for receiving a medical device or a component thereof.Support body 14 may be provided in an initial state in which allportions thereof, i.e., portions 14 a-c, are provided in the same planeand are coupled to each other in a serial fashion, e.g., end-to-end. Inother embodiments, the various support body portions may physicallyoverlap in parts, be stacked on top of each other, or one portion maypartially or completely surround another portion. Referring again toFIG. 1A, the end of main portion 14 a opposite break portion 14 c andrelease portion 14 b may provide an abutment structure or wall 24 tofurther support and retain a medical device 30 on holder 10 (see FIG.3A). Abutment 24, as well as any other surfaces of holder 10, which areexposed after operative engagement with a medical device, may be curved,contoured, rounded, beveled or the like to provide a smooth, lowprofile.

As shown, for example in FIGS. 3A and 4, holder or base unit 10 isconfigured to retain a medical device 30 at medical device area 16(e.g., in and/or on). For example, a medical device 30 may be attachedto a holder 10 on a top surface of support body or unit 14 (see e.g.,FIGS. 3A and 4). As discussed above, base unit 10 may further include atleast one feature that is mateable with a corresponding locking featureon a medical device 30 which is intended to be mounted thereto. As shownin the embodiments of FIGS. 1A-1C, one such cooperating feature includesone or more rails 22 extending along the top surface of at least mainportion 14 a that are configured to engage one or more correspondinggrooves (not shown) on the underside of the medical device. For example,a single rail may extend centrally along a main axis of holder 10 whichcorresponds to centrally extending groove (not shown) on the medicaldevice, or a pair of spaced-apart, parallel rails may be provided onopposing sides of holder 10 corresponding to similarly situated grooveson the medical device. Rails 22 may extend over a first portion 14 aand/or may extend over third portion 14 c, but in many embodiments areabsent from second portion 14 b. Accordingly, in the illustratedembodiment, medical device 30 is mated with holder 10 by aligning afront end of its grooves (not shown) with the rear end of rails 22 andslideably advancing device 30, where such advancement may continue untilit abuts end wall 24. Additionally or alternatively, as shown in FIGS.1C and 3B, another holder, medical device mating or locking feature inthe form of an aperture or receptacle 20 within release portion 14 b,and a corresponding hook or tab 32 extending from a bottom surfacemedical device 30, may be provided. The coupling of these correspondingfeatures may include a snap fit, friction fit or the like, to lock themovement of medical device 30 relative to holder 10. As discussed ingreater detail below, in certain embodiments when holder 10 is alteredand release portion 14 b is displaced from medical device 30, tab 32 isreleased from aperture 20, as shown in FIG. 4, and medical device 30 maybe removed from holder 10, e.g., by sliding it off of rails 22. In thismanner, holder 10 securely yet removeably retains medical device 30.

In the case where medical device 30 includes an implantable or partiallyimplantable glucose sensor, such as with an in vivo glucose monitoringsystem, holder 10 may also include a receiving area such as an aperture18 (FIG. 1A) therethrough for guiding sensor insertion and/or providingsecure electrical contact between the sensor and the sensor control unitto be mounted on holder 10. Receiving area or aperture 18 may bepositioned in, on or at any of a number of areas of holder 10 includingany one or more of portions 14 a-c. In certain embodiments, receivingarea or aperture 18 may include electrical contacts (not shown).

The various portions 14 a-c of holder 10 may be made of the same ordifferent material(s) and/or have the same or different thickness,stiffness, width, length and/or height dimensions. For example, incertain embodiments, enough material thickness may be in transition ofbreak portion 14 c to enable a medical device to be secured to supportbody 14, yet thin enough to enable holder 10 to be altered about portion14 c, e.g., to enable a low force displacement of portion 14 b relativeto portion 14 a and/or portion 14 c. In certain embodiments, portion 14c may have a material thickness about 50% or less of that of portions 14a and/or 14 b. For example, if portions 14 a/14 b have a thicknessdimension of about 1.0 mm, portion 14 c has a thickness dimension ofabout 0.5 mm, requiring a force about 4 to about 12 Newtons to bendand/or break. In other embodiments, the thickness of portion 14 c may besubstantially less than 50% or more than 50% of the thickness of theother portions, requiring a lower or greater amount of force to break orbend. Transition portion 14 c may otherwise include a hinge (e.g., aliving hinge) that is connected to main portion 14 a and release portion14 b to allow release portion 14 b to pivot with respect to the mainportion 14 a. In other embodiments, transition portion 14 c may includea weakened area, detent and/or fracture point. In certain of theseembodiments, scores or perforations may be formed at intervals acrossportion 14 c.

Accordingly, altering holder 10 may include any action resulting in themisalignment, e.g., linear, axial and/or angular misalignment, ofportions 14 a and 14 b relative to each other. Such ability enablestransitioning at least two portions of holder 10 from a medical deviceholding state in which the at least two portions are aligned withrespect to each other to hold a medical device 30 (as shown in FIG. 3A)to a medical device release state in which the at least two portions ofholder 10 are linearly misaligned or offset relative to each other toremove the medical device 30 from the holder 10 (as shown in FIG. 4).The medical device 30 may also be in the holding state for sensorinsertion into the body of a user, and therefore the medical deviceholding state may be characterized as a medical device insertion state.Release portion 14 b may be displaced in any direction relative to mainportion 14 a, e.g., may be moved in the x, y and/or z planes. In certainembodiments, release portion 14 b may be limited to movement in only onedirection, for example release portion 14 b may be limited to movementin the x-plane direction, and in other embodiments, release portion 14 bmay be moveable in two or more directions. In some embodiment, movingrelease portion 14 b may include pivoting it about a pivot point.

For example, as shown in FIGS. 2 and 4, portion 14 b is moveable, e.g.,bendable, away from main portion 14 a, by depressing release portion 14b, to enable medical device 30 to be removed from holder 10 after, forexample, the in vivo operational life of the sensor has elapsed, and/orthe glucose sensor positioned in a user and being used with the systemis otherwise no longer functional. Displacing release portion 14 b maycause it to detach from portion 14 a or at least enable it to bedetached, or it may remain attached. In certain embodiments, secondportion 14 b may be displaced from about 1 to about 90 degrees, e.g.,from about 1 to about 45 degrees. This angular displacement is typicallyaccomplished with the application of a low force to release portion 14b, e.g., by light pressure from a finger.

In certain embodiments, displacement of release portion 14 b relative toat least main portion 14 a may cause medical device 30 to be at leastpartially decoupled or released from holder 10. This decoupling mayfurther include at least initiating movement of medical device 30 in arelease direction. For example, urging portion 14 b in a transverse (orother) direction relative to portion 14 a may cause medical device 30 tomove, e.g., slide, away from a fully engaged, nested position withinholder 10, such as that shown in FIG. 3A. In certain embodiments, holder10 may be configured such that release and/or removal of medical device30 from holder 10 is performed while holder 10 is operatively adhered orfixed to the skin surface, wherein in other embodiments release and/orremoval of medical device 30 from holder 10 is performed while holder 10is not operatively adhered or fixed to the skin surface. Further,medical device 30 may be configured to become inoperable or disabledupon decoupling or release from holder 10 in embodiments to preventfurther use or limit application to only a single use.

It is evident from the above results and discussion that theabove-described disclosure provides devices and methods for maintaininga medical device on-body. The above-described disclosure provides anumber of advantages, some of which are described above and whichinclude, but are not limited to, ease of use, even in instances in whichthe medical device is to be maintained on a body part that is not withinthe direct line of site of the patient, and comfort. Furthermore, thesubject disclosure provides a patient with a high degree of confidencethat the medical device is securely maintained in position on a bodypart. As such, the subject disclosure represents a significantcontribution to the art.

In certain embodiments, a structure adapted for mounting a medicaldevice on the body of a host may comprise a first portion, and a secondportion moveable relative to the first portion, wherein movement of thesecond portion relative to the first portion causes release of at leasta portion of a medical device from the first and second portions whenoperatively mounted thereon.

Certain aspects may include a third portion extending between the firstand second portions, wherein the third portion is configured to bealterable from a first state to a second state to provide the movementof the second portion relative to the first portion.

In certain aspects, the third portion may be one of breakable, bendable,frangible or one or more combinations thereof

In certain aspects, the third portion may comprise one or more of areduced mass, a reduced thickness, a weakened area, a detent, a hinge, afracture point or scoring.

In certain aspects, the third portion may be returnable to the firststate upon being altered to the second state.

In certain aspects, the third portion may be not returnable to the firststate upon being altered to the second state.

In certain aspects, the relative movement may comprise one or more oflinear, axial and angular displacement.

Certain aspects may include at least one feature for releasably couplingwith a corresponding at least one feature of the medical device.

Certain aspects may include a first surface configured for retaining themedical device.

Certain aspects may include a second surface for placement on a skinsurface, wherein the first and second surfaces are on opposing sides ofthe structure.

In certain aspects, the second surface may comprise an adhesive.

In certain aspects, the first portion comprises an abutment forretaining the medical device.

Certain aspects may include an aperture within one of the first andsecond portions for receiving an implantable component of the medicaldevice.

In certain aspects, the aperture may enable electrical contact betweenthe implantable component and another component of the medical device.

In certain embodiments of the present disclosure, a medical deviceassembly configured for temporary positioning on the body of a host maycomprise a medical device having a housing, and a mounting unit adaptedfor mounting on the skin of a host and for releasably retaining thehousing of the medical device in a low-profile position on the host,wherein the mounting unit comprises a displaceable portion and whereindisplacement of the displaceable portion at least partially releases themedical device housing from the mounting unit.

In certain aspects, the displacement provided by the displaceableportion may comprise one or more of linear, axial and angular movement.

In certain aspects, the displaceable portion may be configured to bedisplaced by low-force pressure against the displaceable portion in adirection away from the medical device.

In certain aspects, the medical device may include a feature forreleasably coupling with a corresponding feature of the mounting unit.

In certain aspects, displacement of the displaceable portion of themounting unit may decouple the corresponding features of the mountingunit and the medical device.

In certain aspects, the medical device may comprise a second feature forreleasably coupling with a corresponding second feature of the mountingunit, wherein displacement of the displaceable portion of the mountingunit does not decouple the second corresponding features of the mountingunit and the medical device.

In certain aspects, the mounting unit may have a top surface forretaining a medical device and a bottom surface for placement on a skinsurface.

In certain aspects, the bottom surface of the mounting unit may comprisean adhesive material.

In certain aspects, the top surface of the mounting unit may comprise atleast one feature for releasably coupling to a corresponding feature ofthe medical device.

In certain aspects, the at least one feature of the mounting unit may beat least one rail and the at least one feature of the medical device isat least one groove.

In certain aspects, the at least one feature of the mounting unit may bea receptacle and the at least one feature of the medical device is atab.

In certain embodiments of the present disclosure, a method of using anon body medical device may comprise mounting a medical device on thebody of a host by means of a mounting unit affixed to a skin surface ofthe host, operatively using the medical device for a predeterminedperiod of time, and displacing a first portion of the mounting unitrelative to a second portion of the mounting unit from a first positionto a second position, wherein displaying the first portion relative tothe second portion at least partially releases the medical device fromthe mounting unit.

Certain aspects may comprise replacing at least one component of themedical device, returning the displaced first portion of the mountingunit to the first position, and operatively reusing the medical devicefor the predetermined period of time.

Certain aspects may comprise removing the medical device from themounting unit, replacing at least one component of the medical device,mounting the medical device on the body of the host by means of a secondmounting unit affixed to a second location on the skin surface of thehost, and operatively reusing the medical device for the predeterminedperiod of time.

In certain aspects, the medical device may be an analyte monitoringdevice comprising an electronics unit having a low-profile housing, anda plurality of at least partially implantable analyte sensors, eachsensor being usable for the predetermined time period, wherein themounting unit enables electrical coupling between the electronics unitand one of the plurality of analyte sensors.

In certain aspects, replacing at least one component of the medicaldevices may comprise replacing a used sensor with an unused sensor.

In certain aspects, the predetermined time period may be from about 1day to about 30 days.

In certain aspects, displacing the first portion of the mounting unitrelative to the second portion may comprise one or more of linear, axialand angular movement.

In certain aspects, displacing the first portion of the mounting unitrelative to the second portion may comprise applying a low-forcepressure against the first portion in a direction away from the medicaldevice.

In certain aspects, at least partially releasing the medical device fromthe mounting unit may comprise decoupling a mating feature of themounting unit from a corresponding mating feature of the medical device.

While the present disclosure has been described with reference to thespecific embodiments thereof, it should be understood by those skilledin the art that various changes may be made, and equivalents may besubstituted without departing from the true spirit and scope of thepresent disclosure. In addition, many modifications may be made to adapta particular situation, material, composition of matter, process,process step or steps, to the objective, spirit and scope of the presentdisclosure. All such modifications are intended to be within the scopeof the claims appended hereto.

What is claimed is:
 1. An assembly comprising: a glucose sensorcomprising an in vivo portion which is positionable within a body of ahost, and an ex vivo portion which is positionable outside the body ofthe host and configured to be coupled with an on-body medical device;and a mounting structure configured to hold the on-body medical devicein position relative to a skin surface of the host, the mountingstructure comprising a support body and an adhesive patch configured toaffix the support body to the skin surface of the host, wherein themounting structure further comprises a feature configured to receive atleast a part of the ex vivo portion of the glucose sensor, wherein thesupport body comprises a first portion, a second portion, and afrangible area between the first portion and the second portion, whereinthe support body further comprises at least one opening configured tomate with at least one corresponding tab of the on-body medical device,wherein the at least one opening of the support body and the at leastone corresponding tab of the on-body medical device are configured tosecure the on-body medical device to the support body; wherein thesecond portion of the support body is displaceable relative to the firstportion of the support body, and wherein displacement of the secondportion causes the frangible area to break.
 2. The assembly of claim 1,further comprising the on-body medical device, wherein the on-bodymedical device comprises a housing and data processing and communicationelectronics disposed therein, wherein the on-body medical device isconfigured for electrical communication with the glucose sensor, whereinthe on-body medical device is configured to communicate data indicativeof a glucose level of the host, and wherein the data processing andcommunication electronics of the on-body medical device includes a powersupply, a data storage unit, and a transmitter configured to communicatethe data indicative of the glucose level of the host to a remotelylocated device.
 3. The assembly of claim 2, wherein the first portion islocated between the adhesive patch and the on-body medical device. 4.The assembly of claim 2, wherein the support body is configured suchthat, after the second portion is displaced relative to the firstportion, the on-body medical device can be removed from the support bodyby pulling the on-body medical device in a direction parallel with theadhesive patch and away from the first portion.
 5. The assembly of claim1, wherein the second portion comprises an aperture in a bottom surface.6. The assembly of claim 1, wherein a height of the frangible area isless than a height of the first portion, and further wherein the heightof the frangible area is less than a height of the second portion. 7.The assembly of claim 1, wherein a surface of the first portion of thesupport body is on the adhesive patch and a surface of the secondportion of the support body is on the adhesive patch.
 8. The assembly ofclaim 7, wherein the first portion and the second portion remain on theadhesive patch after the second portion is displaced relative to thefirst portion.
 9. The assembly of claim 1, wherein the second portion ofthe support body is configured to hold a second portion of the on-bodymedical device.
 10. The assembly of claim 1, wherein the mountingstructure further comprises a conductive portion configured toelectrically contact a corresponding conductive portion of the glucosesensor.
 11. The assembly of claim 10, wherein the mounting structurefurther comprises one or more moisture barriers configured to encompassan area proximate to the corresponding conductive portion of the glucosesensor.
 12. The assembly of claim 11, wherein the one or more moisturebarriers comprise an elastomeric material.
 13. The assembly of claim 10,wherein the conductive portion of the mounting structure is furtherconfigured to electrically contact a corresponding conductive portion ofthe on-body medical device.
 14. The assembly of claim 10, wherein thefirst portion comprises the conductive portion of the mountingstructure.
 15. The assembly of claim 1, wherein the support body furthercomprises a gripping portion configured to enable the second portion ofthe support body to be displaced relative to the first portion of thesupport body.
 16. The assembly of claim 15, wherein the gripping portionis disposed on the second portion of the support body.
 17. The assemblyof claim 1, wherein the first portion comprises a rounded end abutmentwall configured to support the on-body medical device, and wherein theat least one opening of the support body is disposed on the rounded endabutment wall.
 18. The assembly of claim 1, wherein the frangible areaincludes two breakable edge portions of the support body.